The QuantStudio™ Dx instrument provides your clinical laboratory with performance you can trust, security you demand, and flexibility you need in your workflow to meet the needs of your lab today and tomorrow.

Flexibility you want
In Test Development Mode, the QuantStudio™ Dx instrument enables the creation of new assays in 96-or 384-well plates, and qPCR Microfluidic Card formats provide easily interchangeable thermal cycling blocks to accommodate your lab’s throughput assay development. The 96-well fast block can be used in IVD mode.

Efficient workflows
A simplified instrument and assay workflow as well as intuitive software makes the entire test—from processing to reporting—efficient and cost-effective. Plus, it frees up highly trained operators to perform more complex tasks. The Quidel® Molecular Direct C. difficile Assay is currently the only approved assay for use in the United States on the QuantStudio™ Dx Instrument with additional assays in development.

What IVD assays are available?

The Quidel® Molecular Direct C. difficile, Influenza A + B and Respiratory syncytial virus (RSV) and human metapneumovirus hMPV assays are the first of our growing assay menu validated for use with the QuantStudio™ Dx Real-Time PCR System. A strong pipeline of assays are currently in development including, Direct HSV 1+ 2/VZV. Our future offerings will also include tests for oncology and inherited diseases.

What formats does the instrument support?

For assay development: qPCR Microfluidic Card, 96-well Fast and standard, and 384-well formats in the US.†

What size is the instrument?

How long does it take to run a typical PCR assay?

Cycle times depend on the test being performed and the thermodynamic requirements. Typically it takes less than 60 minutes from sample acquisition to reporting.

What is the hands-on time?

Approximately 15 minutes. It takes less than 10 minutes to setup the plate, 1 minute to cycle and image, and less than 5 minutes to analyze the data and generate the report.

In Vitro Diagnostics Use.

The QuantStudio™ Dx Real-Time PCR Instrument is for distribution and use in the United States and specific European countries only. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens in IVD labelled tests. The QuantStudio™ Dx Real-Time PCR Instrument with QuantStudio™ Dx Software is intended for in vitro diagnostic use by trained laboratory technologists in combination with nucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument. The QuantStudio™ Dx Real-Time PCR Instrument and accessories also meet the requirements of the EU In Vitro Medical Devices Directive (98/78/EC).

† These blocks are CE-marked in Europe.

§ Applications are intended for research use only in Test Development Mode use only (RUO).

*The Quidel® Molecular Direct C. difficile, Influenza A + B and Respiratory syncytial virus (RSV) and human metapneumovirus hMPV assays are currently the only approved assay for use in the United States,with additional assays in development. Approved assays for use in Europe include the Molecular Direct C. difficile Assay, Influenza A + B, RSV + hMPV, and HSV 1+ 2/VZV Assays.